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Califf Clears First Senate Hurdle, But Could FDA’s Abortion Pill Access Decision Be A Headache?

 
• By Sarah Karlin-Smith

Robert Califf’s nomination to be the next US FDA commissioner squeaked out of the Senate health committee, but a significant number of Republicans are against his confirmation over the agency’s recent decisions on abortion drugs.

Former US FDA Commissioner Robert Califf testified on 14 December, 2021, before the US Senate HELP committee in his bid to lead the agency again
Former US FDA Commissioner Robert Califf testified before the US Senate HELP committee on 14 December in his bid to lead the agency again • Source: Alamy

The US Senate Health, Energy, Labor and Pensions (HELP) committee voted 13-8 on 13 January to advance Robert Califf’s nomination to lead the US Food and Drug Administration. The close vote sharply contrasted with his unanimous vote when he was nominated to lead the agency under President Barack Obama in 2016 and is indicative of a much tougher fight he is likely to face on the Senate floor.

A key stumbling block appears to be the FDA’s recent decision to make it easier for people to access the...

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Surgical Robotics CEOs Talk Metrics For Success, Valuations, Competition And IPO Outlook

 
• By Marion Webb

Leaders of robotic systems companies Distalmotion, Neocis and Noah Medical discussed success metrics, competition and funding. Institutional investors are focusing on utilization, procedure rates and a clear path to profitability as the IPO window reopens, BTIG analyst Ryan Zimmerman said.

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Dxcover Launches US Operations With New Headquarters In Tennessee

 
• By Natasha Barrow

Dxcover sets up new Clinical Laboratory Improvement Amendments (CLIA) lab in Franklin, Tennessee.

Will Kennedy And Makary Come To Terms On User Fees During Next Round Of MDUFA Negotiations?

 
• By Brian Bossetta

It’s no secret that Marty Makary and Robert F. Kennedy Jr. have a different take on user fees, with Makary viewing them as a funding necessity and Kennedy as a corrupting influence. But will they find a way to strike a balance during the next MDUFA reauthorization talks so each can claim victory?

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Dxcover Launches US Operations With New Headquarters In Tennessee

 
• By Natasha Barrow

Dxcover sets up new Clinical Laboratory Improvement Amendments (CLIA) lab in Franklin, Tennessee.

EnsoData Boosts AI Sleep Tech With $20M Series B Funding, Targets Underdiagnosis Crisis

 
• By Shubham Singh

EnsoData positions itself as device-agnostic and interoperable, with FDA-cleared software that can integrate with all major devices. CEO Mortara said this flexibility helps maximize patient reach by enabling both direct provider engagement and integration with device manufacturers.

FDA Blocks Some Olympus Endoscopes From Entering US

 
• By Brian Bossetta

After multiple warning letters and safety communications, the US FDA has decided to block the import of certain endoscopes from Olympus. In total, the agency’s action pertains to 58 device models manufactured by the Japanese firm used in urinary, respiratory, abdominal and pelvic procedures.